Proof of Concept of an Anaplerotic Study Using Brain Phosphorus Magnetic Resonance Spectroscopy in Huntington Disease
TRIHEP2
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this project is to study the efficacy of an anaplerotic treatment on brain energy profile evolution at an early stage of the Huntington disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 18, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
March 24, 2016
CompletedMarch 25, 2026
December 1, 2013
2 months
June 18, 2013
April 30, 2015
March 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Ratio of Inorganic Phosphate (Pi) Over Phosphocreatine (PCr): Pi/PCr
The Pi/PCr Ratio is a measure of brain metabolism and it is an index of mitochondrial oxidative regulation. A 6-cm 31P transmit/receive surface coil (RAPID Biomedical GmbH, Rimpar, Germany) was used to collect free induction decays for 4 minutes at rest, 8 minutes during visual activation with 6-Hz red/black checkerboard flashes, and 8 minutes after stimulation. Subjects were able to focus on the flashes with a nonmagnetic mirror mounted above their eyes while all lights in the room were turned off. The Pi/PCr ratio was then calculated to determine brain response to cortical activation.
visit 1 (baseline), visit 2 (after 1 month of treatment)
Secondary Outcomes (1)
Correlation Between Primary Outcome Measure and Clinical Parameters
1 month
Study Arms (1)
Triheptanoin 1g/kg/day
EXPERIMENTALAll patients received Triheptanoin oil at 1g/kg/day during 1 month
Interventions
Eligibility Criteria
You may qualify if:
- \< UHDRS \< 50
- Age \> 18 years
- Ability to undergo MR scanning
- Covered by french social security
You may not qualify if:
- Evidence of psychiatric disorder
- Attendant neurological disorder
- Contraindications to MRI (claustrophobia, metallic or material implants)
- Severe head injury
- Unable to understand the protocol
- Pregnancy
- Failure to give informed consent
- Unwillingness to be informed in case of abnormal MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brain and Spine Institute
Paris, 75013, France
Related Publications (1)
Adanyeguh IM, Rinaldi D, Henry PG, Caillet S, Valabregue R, Durr A, Mochel F. Triheptanoin improves brain energy metabolism in patients with Huntington disease. Neurology. 2015 Feb 3;84(5):490-5. doi: 10.1212/WNL.0000000000001214. Epub 2015 Jan 7.
PMID: 25568297RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Fanny MOCHEL
- Organization
- Inserm U1127
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2013
First Posted
June 20, 2013
Study Start
May 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
March 25, 2026
Results First Posted
March 24, 2016
Record last verified: 2013-12